Flow sensor system with connection assembly

ABSTRACT

A system for sensing medicament delivery and transmitting an operation modification signal having at least two separable components is disclosed. The system includes a flow sensor having an inlet to couple to a fluid source, an outlet for delivering fluid from the fluid source to a patient, at least one sensor to characterize at least one attribute of the fluid, and at least one pin in in electrical communication with the sensor. The system includes a second component having a base having a contact, a controller in electrical communication with the contact that generates an operation modification signal in response to an attribute matching a condition specified by a rule, a transmitter for transmitting the operation modification signal to a device, the operation modification signal, when received by the device, causing the device to modify at least one operating parameter, and a cross-component electrical circuit.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 62/211,287, filed Aug. 28, 2015, the disclosure of whichis incorporated herein by reference in its entirety.

BACKGROUND OF THE INVENTION

Field of the Disclosure

The present disclosure relates generally to a flow sensor system. Moreparticularly, the present disclosure relates to a flow sensor system forproviding intravenous bolus injections of medication to a patient whichprovides healthcare professionals with an automated record ofmedication, concentration, volume, dose, and time of each injection.Preferably, the system has an ultrasonic flow sensor.

Description of the Related Art

There is a need to reduce medication error at bedside during bolusdelivery. It would be advantageous to provide a record of, andelectronically measure, bolus delivery which allows monitoring bolusdelivery and automatic documentation of bolus delivery as part of apatient's health record. Additionally, it would be advantageous toprovide alerts when bolus delivery inconsistent with a patient's medicalrecord is about to occur.

SUMMARY OF THE INVENTION

The present disclosure provides a system for sensing flow of a fluidicmedicament. The system includes an intelligent injection port which mayattach to an injection site (such as a “Y Site” or a stop cock) formanually administered IV injections. The system includes two mainsub-assemblies: a single-use flow sensor and a reusable base unit, whichfit together prior to use.

In accordance with an embodiment of the present invention, a system forsensing medicament delivery and transmitting an operation modificationsignal having at least two separable components includes a firstcomponent and a second component. The first component includes a flowsensor having a fluid port having a flow tube, a fluid inlet at a firstend of the flow tube adapted to couple to an outlet of a fluid source,and a fluid outlet at a second end of the flow tube adapted to deliverfluid from the fluid source to a fluid pathway that provides fluid to apatient. The first component also includes at least one sensor tocharacterize at least one attribute of the fluid from the fluid source,and at least one pin in electrical communication with the at least onesensor. The second component includes a base having at least onecontact, and a controller in electrical communication with the at leastone contact that generates the at least one operation modificationsignal in response to at least one attribute matching at least onecondition specified by at least one rule. The second component alsoincludes a transmitter for wirelessly transmitting the operationmodification signal to at least one device, the operation modificationsignal, when received by the at least one device, causing the at leastone device to modify at least one operating parameter, and across-component electrical circuit. The flow sensor is mountable ontothe base and the cross-component electrical circuit is a connection madeby the contacts engaging the pins.

In certain embodiments, the flow sensor also includes end fittingsadapted for securing the flow tube to the end fittings and first and asecond piezo elements that are mounted to the end fittings. The flowtube may be a stainless steel material. The first piezo element and thesecond piezo element may be annular in shape and encircle the flow tubeat each respective mounting point.

The flow sensor may be disposed of after the flow sensor is used togenerate one operation modification signal. The base may be used with adifferent flow sensor. In certain configurations, the flow sensorfurther includes cantilevered wings adapted for securing the flow sensorto the base. The flow sensor may include a follower and the base mayinclude a cam wherein the follower follows at least a portion of the camwhen the flow sensor is mounted to the base.

In other configurations, the flow sensor includes an opening and thebase further includes a protrusion wherein the opening is sized andshaped to engage the protrusion and the protrusion enters the openingwhen the flow sensor is mounted to the base. The flow sensor may includean opening and the base may include a protrusion wherein the opening issized and shaped to engage the protrusion and the cam is adapted to movethe pin away from the protrusion while the protrusion enters the openingwhen the flow sensor is mounted to the base.

The flow sensor may include at least one cantilevered wing having a tabadapted for securing the flow sensor to the base by engagement of thetab to at least one lip in the base. The at least one cantilevered wingmay be deflectable in a direction to allow the tab to release from theat least one lip, thereby allowing the flow sensor to become de-mountedfrom the base. The at least one cantilevered wing may be a pair ofcantilevered wings. In certain configurations, the at least onecantilevered wing may be a pair of cantilevered wings and eachrespective wing may be arranged opposite each other and the opening isspaced away from the wings, and the opening has a center position whichbisects a distance between the cantilevered wings and the at least onefollower is a pair of followers and each respective follower is arrangedopposite each other on the flow sensor. In another configuration, the atleast one cantilevered wing is a pair of cantilevered wings and eachrespective wing is arranged opposite each other and the opening isspaced away from the wings, and the opening has a center position whichbisects a distance between the cantilevered wings.

In certain configurations, the system further includes a seal for aliquid-tight engagement between the flow sensor and the base, whereinthe seal surrounds the cross-component electrical circuit, therebysealing the cross-component electrical circuit from contamination by aliquid. The flow sensor may also include cantilevered wings having a tabadapted for securing the flow sensor to the base by engagement of thetab to a lip in the base.

In accordance with another embodiment of the present invention, a systemfor sensing medicament delivery and transmitting an operationmodification signal having at least two separable components includes afirst component and a second component. The first component includes aflow sensor having a fluid port having a flow tube, a fluid inlet at afirst end of the flow tube adapted to couple to an outlet of a fluidsource, and a fluid outlet at a second end of the flow tube adapted todeliver fluid from the fluid source to a fluid pathway that providesfluid to a patient. The first component also includes at least onesensor to characterize at least one attribute of the fluid from thefluid source, and a movable detector which detects a coupling of theoutlet of the fluid source to the fluid inlet of the flow sensor. Thesecond component includes a base having a controller that generates theoperation modification signal in response to at least one attributematching at least one condition specified by at least one rule, a switchfor activating said controller, and a transmitter for wirelesslytransmitting the operation modification signal to at least one device.The operation modification signal, when received by the at least onedevice, causes the at least one device to modify at least one operatingparameter. The flow sensor is mountable onto the base and the movabledetector engages the at least one switch, thereby activating thecontroller.

In certain configurations the flow sensor further includes cantileveredwings adapted for securing the flow sensor to the base. The flow sensormay include a follower and the base further includes a cam wherein thefollower follows at least a portion of the cam when the flow sensor ismounted to the base. The flow sensor may further include an opening andthe base further includes a protrusion wherein the opening is sized andshaped to engage the protrusion and the protrusion enters the openingwhen the flow sensor is mounted to the base. The flow sensor may alsofurther include an opening and the base further includes a protrusionwherein the opening is sized and shaped to engage the protrusion and thecam is adapted to move the pin away from the protrusion while theprotrusion enters the opening when the flow sensor is mounted to thebase.

The flow sensor may also include cantilevered wings having a tab adaptedfor securing the flow sensor to the base by engagement of the tab to alip in the base. The detector may include a cantilevered beam protrudingfrom a portion of the flow sensor. The cantilevered beam may have a freeend which engages the switch by deflection of the cantilevered beam.Optionally, the detector may include a cantilevered beam protruding froma portion of the flow sensor, the cantilevered beam having a free endhaving an outlet engaging portion extending in a direction generallyperpendicular to the cantilevered beam. The detector may also include aswitch engaging portion of the free end extending in a directiongenerally opposite to the outlet engaging portion.

The flow sensor can include a vault that covers a portion of the basethus forming a protective layer to limit contamination of the reusablebase from adhesive residue, blood spatter or other bodily fluids,dripping fluids from IV lines, and the like. In addition, the vault mayallow for easier sterilization and cleaning for subsequent patient use.

In accordance with another embodiment of the present invention, a systemfor sensing medicament delivery and transmitting an operationmodification signal having at least two separable components includes afirst component and a second component. The first component includes aflow sensor having a fluid port having a flow tube, a fluid inlet at afirst end of the flow tube adapted to couple to an outlet of a fluidsource having a target, and a fluid outlet at a second end of the flowtube adapted to deliver fluid from the fluid source to a fluid pathwaythat provides fluid to a patient. The first component also includes atleast one sensor to characterize at least one attribute of the fluidfrom the fluid source. The second component includes a base having aportal, a controller in communication with an optical sensor having anaxis that extends through the portal and inputs a signal to thecontroller, and wherein the controller generates the at least oneoperation modification signal in response to at least one attributematching at least one condition specified by at least one rule. Thesecond component may also include a transmitter for wirelesslytransmitting the operation modification signal to at least one device,the operation modification signal, when received by the at least onedevice, causes the at least one device to modify at least one operatingparameter. When the flow sensor is mounted onto the base the opticalsensor axis is aligned with the target.

In certain configurations, the target is indicia on the outlet of thefluid source. The flow sensor may also include a follower and the basemay further include a cam wherein the follower follows at least aportion of the cam when the flow sensor is mounted to the base.Optionally, the flow sensor further includes an opening and the basefurther includes a wedge-like protrusion wherein the opening is sizedand shaped to accommodate a widest portion of the wedge-like protrusionand the optical sensor axis is aligned with the target when the widestportion enters the opening as the flow sensor is mounted to the base.The flow sensor may also include an opening and the base may furtherinclude a protrusion wherein the opening is sized and shaped to engagethe protrusion and the cam is adapted to move the pin away from theprotrusion while the protrusion enters the opening when the flow sensoris mounted to the base and when the follower is at a final position ofthe cam, the optical sensor axis is aligned with said target.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a distally-directed perspective view of a flow sensor systemin accordance with an embodiment of the present invention.

FIG. 2 is a proximally-directed perspective view of a flow sensor systemin accordance with an embodiment of the present invention.

FIG. 3A is a proximal elevation view of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 3B is a distal elevation view of a flow sensor system in accordancewith an embodiment of the present invention.

FIG. 4A is a side elevation view of a flow sensor system in accordancewith an embodiment of the present invention.

FIG. 4B is an enlarged detail view of a portion of FIG. 4A asillustrated by Detail A.

FIG. 5A is a perspective view of a base of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 5B is a perspective view of the base of FIG. 5A illustrating theoptical and electrical components.

FIG. 6 is a perspective view of a flow sensor of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 7 is another perspective view of a flow sensor of a flow sensorsystem in accordance with an embodiment of the present invention.

FIG. 8 is an exploded, perspective view of a flow sensor of a flowsensor system in accordance with an embodiment of the present invention.

FIG. 9 is a perspective view of a flow sensor of a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 10A is a side elevation view of a syringe compatible with a flowsensor system in accordance with an embodiment of the present invention.

FIG. 10B is an enlarged detail view of a portion of FIG. 10A asillustrated by Detail B.

FIG. 10C is a side elevation view of a tip label for a syringecompatible with a flow sensor system in accordance with an embodiment ofthe present invention.

FIG. 11A is a perspective view of a charger for a flow sensor system inaccordance with an embodiment of the present invention.

FIG. 11B is an enlarged detail view of a portion of FIG. 11A rotated ata clockwise angle as illustrated by Detail C.

FIG. 11C is a top elevation view of a charger for a flow sensor systemin accordance with an embodiment of the present invention.

FIG. 11D is a cross-sectional view taken along line X-X of FIG. 11C,with a base of a flow sensor system received within a portion of thecharger, in accordance with an embodiment of the present invention.

FIG. 12 is a perspective view of a flow sensor and a mount in accordancewith an embodiment of the present invention.

FIG. 13 is a perspective view of a flow tube sub-assembly in accordancewith an embodiment of the present invention.

FIG. 14A is a schematic representation of a computer display in ananesthesia view in accordance with an embodiment of the presentinvention.

FIG. 14B is a schematic representation of a computer display in atabular view in accordance with an embodiment of the present invention.

FIG. 15 is a perspective view of a circuit board in accordance with anembodiment of the present invention.

FIG. 16 is a perspective view of a flow sensor in accordance with anembodiment of the present invention.

FIG. 17A-C are block diagrams of a flow sensor system in accordance withan embodiment of the present invention.

FIG. 18A-D are block diagrams of a flow sensor system in accordance withan embodiment of the present invention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

As used herein, proximal shall refer to a part or direction located awayor furthest from a patient (upstream), while distal shall refer to apart or direction towards or located nearest to a patient (downstream).Also, a drug substance is used herein in an illustrative, non-limitingmanner to refer to any substance injectable into the body of a patientfor any purpose. Reference to a patient may be to any being, human oranimal. Reference to a clinician may be to any person or thing givingtreatment, e.g., a nurse, doctor, machine intelligence, caregiver, oreven self-treatment.

FIGS. 1-12 illustrate an exemplary embodiment of a flow sensor system200 of the present disclosure. Referring to FIGS. 1-12, a flow sensorsystem 200 of the present disclosure includes two main assemblies whichfit together prior to use: a flow sensor 210 and a base 220. In oneembodiment, the flow sensor 210 can be a single-use flow sensor which isengageable with reusable base 220. The flow sensor system 200 is anintelligent injection port. The flow sensor system 200 is attachable toan injection site (“Y Site” or stop cock, for example) for manuallyadministered IV injections.

The flow sensor system 200 of the present disclosure can reducemedication error at bedside during bolus delivery. The flow sensorsystem 200 of the present disclosure can also provide a record of andelectronically measure bolus delivery, which allows monitoring bolusdelivery and automatic documentation of bolus delivery as part of apatient's health record. The flow sensor system 200 of the presentdisclosure can also provide alerts when bolus delivery inconsistent witha patient's medical record is about to occur.

Referring to FIGS. 1-5, in one embodiment, the base 220 is anon-sterile, reusable device that houses a battery, a scanner (eitheroptical, mechanical, inductive, capacitive, proximity, or RFID),electronics, and wireless transmitter. In some embodiments, the base 220is battery powered, and rechargeable. In some embodiments, each base 220has a unique serial number imprinted on a surface of the base 220 orembedded therein that may be transmitted to a data system before use.The data system can be a local computer or tablet “Computer”, a cellularphone, another medical device, or a Hospital Data System.

In one embodiment, the base 220 is removably connectable to the flowsensor 210. Referring to FIGS. 5A and 6-9, the base member 220 and themechanical connection of the flow sensor 210 to the base member 220 isdescribed. The base member 220 includes at least one deflectable wingtab 280 defining an opening for receiving at least a portion of the flowsensor 210 therein and for securing the flow sensor 210 within a portionof the base 220 prior to use. In one embodiment, a pair of wing tabs 280secure the flow sensor 210 within the base 220. Optional gripping ribs395 may be provided on an exterior profile for enabling a user to graspthe base portion 220.

An interior profile of the wing tab 280 may be provided with a catch 389for corresponding engagement with a tab 189 provided on the flow sensor210, as shown in FIG. 6, to restrain the flow sensor 210 within the base220, as will be discussed further herein. The wing tabs 280 may beflexible to the extent that they may be outwardly deflected to allow forpassage of the flow sensor 210 thereover. The interior of the wing tab280 may be provided with a pin cam 388 which allows a pin 188 of theflow sensor 210, as shown in FIG. 7, to ride along such that the flowsensor 210 is moved proximally during assembly onto the base 220, toprecisely align various optical and electrical components of the flowsensor 210 and the base member 220, as will be discussed further herein.

Referring to FIGS. 5B and 6-9, the base member 220 and the electricalconnection of flow sensor 210 to the base member 220 is described. Thebase 220 includes an activation/engagement button 350 which allows foran indication that the flow sensor 210 has been engaged with the base220. In one embodiment, the activation/engagement button 350 signals toa microprocessor within the base 220 that a syringe has been properlyengaged with the sensor 210 and its injection port 130.

The base 220 further includes a plurality of contacts 386 (FIG. 5B) forelectrically engaging corresponding electrically active portions of theplurality of contact pins 385 (FIG. 7). A contour protrusion 488surrounds at least a portion of the tongue 286. As shown in FIG. 7, abottom surface of the sensor 200 includes a pin seal 384 surrounding aplurality of contact pins 385 to prevent contamination, thus minimizingelectrical disruptions. In some embodiments the plurality of pins 385comprise a four pin connector with two pins electrically connected toeach piezo element 150, 151, as will be discussed further. In otherembodiments, the plurality of pins 385 comprise a six pin connector withtwo pins electrically connected to each piezo element 150, 151 and twopins electrically connected to a battery (not shown) in the flow sensor210.

The base member 220 further includes a tongue 286 surrounded by ashoulder 486 having a plurality of contacts 386 for electricallyengaging corresponding electrically active portions of sensor 200 and acharger 900 (FIG. 11A), as will be discussed herein.

Referring to FIGS. 1-4B, 6-9, and 13, in one embodiment, the flow sensor210 is a pre-sterilized disposable having an injection port 130 and adistal tubing connection, such as a Luer tip 109.

The flow sensor 210 may include a flow tube sub-assembly 10 consistingof a flow tube 100 having an outlet end 101 and an inlet end 102. Theoutlet end 101 may be provided in fluid communication with an outlettubing 110 having an outlet connection 105 including a Luer tip 109which may be optionally covered by a Luer cap 108. In a preferredembodiment, the outlet connection 105 is a plastic connector with a Luertip 109, however, any suitable method to inject the medicament into apatient is envisaged to be within an aspect of an embodiment of theinvention. For example, it may be desirable to replace the outletconnection 105 and tubing 110 with a needle for directinjection/infusion into a patient. Furthermore, it may be desirable tointegrate the base 220 into a medication pen or infusion device for thedelivery of insulin.

The inlet end 102 may be coupled to the reservoir of a medication pen orinfusion reservoir. The inlet end 102 of the flow tube 100 may beprovided in fluid communication with an injection port 130, and mayoptionally include a connection such as a threaded Luer lock 131 whichis engageable with a source of a fluid to be injected. A pierceableseptum 139 may be provided with the injection port 130 for maintainingsterility prior to use.

In a preferred embodiment, the injection port 130 is a plastic containerwith a split septum 139, however, any suitable method to inject themedicament through a flow sensor inlet 180 to a patient is envisaged tobe within an embodiment of the present invention. For example, it may bedesirable to replace the injection port 130 for direct connection to amedicament delivery device. In addition, it may be desirable tointegrate the flow sensor inlet 180 to accept a direct fluidicconnection to a medication delivery device.

In one embodiment, the flow tube 100 is comprised of a medical gradestainless steel and is approximately 50 mm long with a 1.0 mm innerdiameter and a 1.6 mm outer diameter.

The flow sensor 210 also includes a first piezo element or upstreamtransducer 150 and a second piezo element or downstream transducer 151.The first piezo element 150 may be provided with an inlet fitting 180,as shown in FIG. 8, for coupling with the injection port 130. Similarly,the second piezo element 151 may be provided with an outlet fitting 190,for coupling with the outlet tubing 110.

The flow sensor 210 can be supplied in a sterile package for a singlepatient use. In one embodiment, labeling is printed on the individualsterile package. In one embodiment, each flow sensor 210 has a uniqueserial number imprinted on a portion of its surface. In someembodiments, there are electronics in the flow sensor 210 which retain aunique identifier. These identifiers are transmitted eitherautomatically or manually to a data system during use and datacollection. In one embodiment, at the inlet end 102 of a flow sensor 210the injection port 130 is a common needleless, Luer-Lok type. Typically,the inlet port or the injection port 130 is cleaned prior to giving aninjection according to hospital policy. Additionally, flushing the flowsensor 210 with an IV fluid (e.g., normal saline syringe) is desirablebefore use. The injection port 130 on the flow sensor 210 typicallysupports up to 100 injections. In one embodiment, the flow sensor 210has a male Luer-Lok connection, e.g., an outlet connection 105 having aluer tip 109, on a one-inch IV tubing pigtail at the outlet end 101.This male Luer-Lok connection may be attached to an IV line at a Y-siteor IV manifold. Each flow sensor 210 has a unique serial number, howeverit may be desirable to only display a portion of the serial number on aportion of the exterior of the flow sensor 210. For example, the last 4digits of the serial number may be imprinted on the surface next to itsbar code. This human readable number is used to visually identify a flowsensor 210 within wireless range of communication of a computer. In someembodiments, the flow sensor 210 measures with an accuracy of ±5% forbolus volumes of 1.0 mL to 55 mL and ±20% for bolus volumes of 0.4 to1.0 mL and has a dead-space volume of less than 0.3 mL.

Referring to FIGS. 11A-11D, in one embodiment, an optional separatecharger 900 is compatible with the flow sensor system 200 and rechargesa battery in the reusable base 220, if required, for reuse of the base220. Referring to FIGS. 11A-11D, in one embodiment, the charger 900includes a charger base 905 having an opening 925 for receiving the base220, the opening 925 having charging pins 950 which engage correspondingcontacts 386 in the reusable base 220. The charger 900 may include asloped floor 930 for allowing disinfection liquid to drain therefrom.The device may also include elevated feet 999 to assist in drainage.

Reusable bases are typically supplied non-sterile and requiredisinfection and charging before use. It is preferred to disinfect eachbase 220 before first use. Typical commercial hospital disinfectantsinclude alcohol-based quaternary ammonium, e.g., Metrex Research CaviWipes. In some embodiments, the base 220 can be used up to 500 times.Preferably, a rechargeable lithium ion battery is used within the base220 and is not removable from the base 220. It is envisaged that afully-charged base 220 will accommodate an entire patient case. In someembodiments, each base 220 is identified by labeling on the bottom ofthe device. Optionally, bases 220 are provided in individual boxes andeach box is in a case package. The charger 900 may also include a powerindicator 995. In one embodiment, when the base 220 is connected to acharger 900, up to four green light bars will illuminate on the top. Thenumber of solid green light bars indicates the level of charge. A greenblinking light on the base 220 will indicate it is recharging. In someembodiments, a useful life indicator is employed when the base 220 isconnected to a charger 900 by use of a red light that indicates that thebase 220 has exceeded its useful life. Optionally, on the Computer, anerror message will display when a flow sensor system 200 whose usefullife is completed is wirelessly connected to a tablet during patientsetup. It would then be desirable to replace the base 220 with anotherand repeat the wireless connection to the Computer. Optionally, the flowsensor system 200 is provided in a mount which is an appliance that fitsa standard Clarke socket to keep the flow sensor system 200 in place atthe patient's bedside. Additionally, it may be desirable to clean anddisinfect the charger 900 by using the procedure used for cleaning anddisinfecting the base 220.

In one embodiment, the flow sensor system 200 supports injections usingany Luer-lock type syringe. For example, referring to FIGS. 10A-10C, theflow sensor system 200 is compatible with a syringe 800 that is labeled.In one embodiment, the syringe 800 includes scale markings 805, a distaltip 810, a luer tip 815, a proximal end 820, a flange 825, a tip label850 having human readable indicia 852 and machine readable indicia 854,a barrel label 860 having human readable indicia 862, and a plunger 890.

The base 220 of the flow sensor system 200 includes optics and a digitalcamera disposed within or behind a first window 360 (FIG. 2) capable ofreading the machine readable indicia 854 provided on a label 850 of anencoded syringe. The first window 360 may be precisely aligned with Luerlock threads 131 present on the flow sensor 210 when the flow sensor 210is assembled with the base 220, thus aligning the machine readableindicia 854 present on the label 850 on the syringe 800 during aninjection cycle and/or medication determination cycle. The base 220 mayfurther include a second window 370 (FIGS. 5A and 5B) having a lightsource for providing adequate lighting to the camera disposed within orbehind window 360.

Additionally, the flow sensor system 200 is designed to work withencoded syringes that have a special barcode identifier on the Luercollar of the syringe, called “encoding”. Preferably, encoded syringesinclude commercially-available drugs in prefilled syringes with aspecial barcode that stores information about the medication containedwithin the syringe. Encoded syringes are ready-to-use, passive, anddisposable. The flow sensor system 200 also accommodates syringes nothaving encoding. The encoding syringes store the drug name andconcentration contained within the syringe. Additional characteristicssuch as drug source, container size, drug manufacturer source, drugcategory color, among others, may also be included. When an encodedsyringe is attached to the injection port 130 of the flow sensor 210,this barcode information is read by a scanner in the base 220 wirelesslytransmitted by the flow sensor system 200 to the data system.Preferably, the 2-D barcodes will be added to syringes during thefilling process.

In one embodiment, the flow sensor system 200 contains a device tocapture and transmit an image of a 2-D barcode on the Luer collar of thesyringe, and wirelessly transmit this image to a “Computer”. Typicallythe Computer is a tablet computer communicating with multiple flowsensor systems 200. The 2-D barcode contains data, typically includingthe name and concentration of the drug in the syringe among other data.The Computer decodes this image, and displays and announces the drugattached. The barcode can contain the drug name and concentration. Asthe drug is injected, the flow sensor 210 in conjunction with the base220 ultrasonically measures the volume of the injected drug and the timethe drug was administered. This information may be stored in the flowsensor system 200 for later transmission to the Computer. The Computeruses this information to provide clinicians with an automated record ofthe drug name, concentration, volume, dose, and time of injection. Themedication administration information is time stamped and displayed forclinical reference. Not all syringes used by the healthcare professionalwill contain a 2-D barcode. If a syringe without a 2-D barcode isinserted into the flow sensor system, the injection port 130, the flowsensor system 200 will prompt the user to manually enter the drug nameand concentration into the computer. Information that is manuallyentered into the flow sensor system 200 is included in the patientmedication record.

In one embodiment, the Computer can use a radio to wirelesslycommunicate with the flow sensor system 200 using an RF signal at 2.4GHz to form a local medical device network. A number of flow sensorsystems 200 and Computers may be used in the same vicinity such as apre-operative care area or a post anesthesia care unit (PACU). Alertmessages are communicated between the flow sensor system 200 and theComputer to advise the clinician of various operational characteristicsof the flow sensor system 200. Some of these alerts inform the clinicianof potential hazardous situations to allow user action to prevent harmto the patient or loss of medical data. Preferably, a lost wirelesscommunication message will display when communication is lost betweenthe flow sensor system 200 and the Computer. Preferably, all medicationadministration data from the flow sensor system 200 is transferred tothe specific patient's medical record. In the event of a communicationloss, medication administration data will be stored locally at the flowsensor system 200 and transferred to the Computer when communicationsare resumed.

The Computer may operate in a variety of modes. Typically the Computerhas specialized flow sensor system 200 software for operations, a touchscreen, and a wireless communications (Radio). It is typically mountednear an anesthetist or nursing work envelope and it may be removed forhand-held use. When the Computer is used in a hospital having a paperanesthesia record, the Computer supports features that assist withdocumenting the flow sheet portion and may help clinicians make theright decisions. In this configuration, the Computer complements thepaper recordkeeping activities by tracking and displaying injectionsgiven through the flow sensor system 200. The Computer also enablesclinicians to manually document other pertinent IV drug injection andinfusion information.

In one embodiment, the software screens follow a three-step approachconsisting of: (1) connecting the flow sensor system 200 to theComputer; (2) setting up a patient's flow sensor system 200 for use; and(3) viewing medication administration in multiple views.

In some embodiments, a view on the computer displays anesthesia basedinformation in an anesthesia view, as shown in FIG. 14A. Preferably,this view provides information about the patient and displays drugname/concentration and dose for a current injection as well as ahistorical list of medications that have been delivered to the patientsince the current case was opened. It may also include a listing ofinfusions given to the patient, if the clinician recorded them on theComputer. In this view, up to three injection bars display across thetop of the screen, one corresponding to each wirelessly connected flowsensor system 200. Each injection bar is a real time representation ofthe medication being administered through an individual flow sensorsystem 200. When an encoded syringe is attached to a single flow sensorsystem 200, the injection bar displays the drug name and concentration.When a non-encoded syringe is attached, the injection bar will promptthe clinician to identify the medication and concentration beingdelivered. As the medication is being delivered, the volume pushed (inmL) and the corresponding dose displays in real time in the injectionbar on the Computer display.

A flow sensor system 200 of the present disclosure may also provideoptional medication history. For example, as shown in FIG. 14A, theanesthesia view can include a historical list of medications deliveredto the patient organized by the surgical care area (medications given inthe transition time between care areas, will post to the next care area)arranged in a flow sheet format. Preferably, this view includes allmedications that were administered to the patient since the flow sensorsystem 200 was activated with the more recent medication administrationspreferably at the bottom of the list. A scroll bar is enabled when thelist exceeds the visible space on the screen of the Computer.Preferably, when a new medication is added, the medication list scrollsautomatically so the new medication name is visible. In the view,preferably a color tile corresponding to American Society for Testingand Materials International (ASTM) standards and endorsed by theAmerican Society of Anesthesiologists displays to the left of the drugname. Optionally, a clinician may also specify that an admixture (mixedmedication), or a diluted or reconstituted medication was delivered.Optionally, the Computer displays a case header which lists the patientname, date of birth, age in years, medical record number, and patientidentification number. Optionally, the Computer will indicate that thepatient has “no known allergies”. Preferably, if the patient hasallergies, that text is replaced by a button, more preferably, and thebutton has a number on the button that indicates the number ofallergies.

A flow sensor system 200 of the present disclosure may also provide anoptional tabular view, as shown in FIG. 14B. For example, the tabularview is an alternate view for the clinician to interact with the flowsensor system 200. Similar to the anesthesia view described above, thisview provides information about the patient and displays drugname/concentration and dose for a current injection as well as ahistorical list of medications that have been delivered to the patient.It may also include a listing of infusions given to the patient, ifrecorded by the clinician. The tabular view has many of the features ofthe anesthesia view; however, it is arranged in a tabular format.Preferably, the column headings in this view include time administered,medication with concentration, dose, and unit total. Optimally, themedications are displayed in reverse chronological order with mostrecent medication administered at the top of the list.

In one embodiment, the Computer provides two types of messages: (1)“Clinical” and (2) “System”. Clinical messages are alerts and remindersthat relate directly to an aspect of patient care delivery (e.g.contraindication or a reminder that it may be time to re-doseantibiotics). System messages provide status on relevant systemoperating parameters.

Messages provide instructions and a button for acknowledging orresolving. Messages display on the Computer until they are acknowledgedor are no longer clinically relevant. Messages can be answered any timeduring a case. Prior to pausing or closing a case, the clinician isprompted to respond/answer unresolved medication messages generatedduring the case. An allergy alert illuminates the flow sensor system 200and displays on the Computer when a clinician attaches an encodedsyringe or selects a medication for a non-encoded syringe to which thepatient has a known allergy. Optionally, this message may be overridden.

When dosing antibiotics, preferably the Computer tracks elapsed timesince an antibiotic was last administered and displays and announces anantibiotic redosing message if the configured redosing interval haselapsed. The redosing interval is individual to each antibiotic, and itis configured in the drug library of the Computer or Gateway (furtherdescribed below). In one embodiment, the flow sensor system 200 does notprevent or block the injection of a medication. In other embodiments,the flow sensor system 200 is able to block the injection of amedication.

In one embodiment, the Computer posts a message when the volume injectedthrough the flow sensor system 200 was not measured. This may occur whenthe volume measured is outside of a range of sensing of the flow sensorsystem 200.

Optionally, the Computer wirelessly communicates bi-directionally with asoftware application that acts as a central hub to which all Computers(and thus multiple upon multiples of flow sensor systems 200) areconnected, the “Gateway”. Preferably, the Gateway is also connected tothe hospital's other networked information systems. The Gateway allowsall Computers to share patient case information such as drug name, dose,and time delivered with each other, and with the hospital's networkedinformation systems. The Gateway also allows Computers to receivepatient information such as patient drug allergies and patient drugorders from other networked hospital information systems.

Utilizing the flow sensor system 200 of the present disclosureencompasses the steps of connecting the flow sensor 210 to the patient'scatheter or injection port (Y-site). Preferably, the flow sensor 210 andline is flushed. The flow sensor 210 is keyed to an individual patientusing a unique serial number and the base 220 records medicationadministration through the port at the inlet end 102 of the flow sensor210.

When a syringe 800 is attached to the injection port 130, the flowsensor system 200 identifies the medication and concentration for anencoded syringe by optically imaging and decoding a barcode on theLuer-Lok collar of the syringe 800. This information is wirelesslytransmitted to the Computer. Preferably, the Computer displays andaudibly announces the drug attached. The Computer also may performallergy safety checks based on the patient's medical record.

In one embodiment, as the drug is injected, the flow sensor system 200measures the volume dosed ultrasonically. The flow sensor system 200wirelessly sends volume measurement information to the Computer. TheComputer uses this information to provide clinicians with a medicationadministration record which is time stamped and displays for clinicalreference during surgical procedures. Manually entered infusions andother information pertaining to non-encoded drug injections may beincluded in the patient medication record in the Computer and theGateway. The Computer wirelessly communicates with the Gateway on thehospital network, and it may send medication administration to HospitalInformation Systems, when configured, for reporting and electronicrecordkeeping purposes. Preferably, the Computer wirelessly communicateswith the existing Hospital Network using a standards based IEEE802.11a/b/g/n enterprise WLAN network. The Gateway software andaccompanied database will be a part of the hospital's enterpriseinformation system. A number of Computers may be connected to thehealthcare enterprise wireless network and to the intended Gatewaysoftware and database. Preferably, the Gateway and accompanied databaseprovides a list of patients for the user to select and a formularylibrary of medications and fluids for injection or infusion. In oneembodiment, actual medication and fluid administration data are sent tothe Gateway and accompanied database for recordkeeping. Once recorded onthe Gateway and accompanied database these data are preferably availablein other care areas when the patient is transferred and the flow sensorsystem 200 is wirelessly connected to a Computer. Preferably, in theevent of a communication loss, medication administration data will notbe sent to the Gateway and therefore not available in the next carearea.

Referring to FIGS. 1-12, use of a flow sensor system 200 of the presentdisclosure will now be described. First, preparing the flow sensorsystem 200 for an injection will be discussed.

In one embodiment, the flow sensor system 200 is prepared, attached toan IV line, and assembled for use. Preferably, there are pre-printedinstructions located on the flow sensor 210 sterility pouch. First, auser obtains a flow sensor 210 in its sterile packaging and afully-charged and disinfected reusable base 220. In one embodiment, afully-charged base 220 has sufficient power for at least 24 hours of useunder typical conditions. Optionally, the base 220 provides a visualindication of charge level via a display.

Next, the flow sensor 210 is flushed with sterile IV fluid beforeattaching to the Y-site. In one embodiment, the flow sensor 210 isflushed with more than 8 mL of sterile IV fluid. After flushing, a usercan visually inspect the IV line for leaks, air, or blockage.

Next, a user attaches the flow sensor 210 to the base 220 by joining theflow sensor 210 (tubing side) and base 220 front sections first, andthen snapping the two together. Preferably, an audible snapping sound isheard to indicate a secure connection between the flow sensor 210 andthe base 220. In one embodiment, connecting the flow sensor 210 to thebase 220 automatically powers on the flow sensor system 200. In oneembodiment, the connection of the flow sensor 210 to the base 220 isverified by a blinking light on the base 220. In other embodiments,other indicators may be used. Catch 389 of the base 220, shown in FIG.5A, engages tab 189 of the flow sensor 210, shown in FIG. 6, to restrainthe flow sensor 210 with the base 220 prior to initiation of aninjection. In one embodiment, deflection of the wing tab or wing tabs280 moves tab 189 with respect to catch 389 to initiate engagement ordisengagement therewith. When the flow sensor 210 is assembled to thebase 220, a cantilever 650 provided on the base 220, such as a lowerhousing 212 as will be discussed herein, is aligned with button 350provided on the base 220. The interior of the wing tab 280 may also beprovided with a pin cam 388 which allows pin 188 of the flow sensor 210,as shown in FIG. 6, to ride along such that the flow sensor 210 is movedproximally during assembly onto the base 220. During engagement, tongue286 shown in FIG. 5A, is engaged within an opening 285 shown in FIG. 7.With continued reference to FIGS. 5A and 7, a vault 485 having ribs 487on the flow sensor 210 as shown in FIG. 7, has a corresponding exteriorprofile taken with the shoulder 486 of the base 220, as shown in FIG.5A, to engage for alignment of the first window 360 to precisely alignwith Luer lock threads 131 when the flow sensor 210 is assembled to thebase 220. The vault 485 may provide a covering portion, such as a hollowcover, which forms a protective layer around the bottom portion of thebase 220 to limit contamination, particularly to limit contamination ofthe pin seal 384 surrounding the plurality of contact pins 385. In oneconfiguration, the vault 485 is a depending skirt that minimizes contactof the bottom of the base 220, such as the contact pins 385, and reducescontamination from from adhesive residue, blood spatter or other bodilyfluids, dripping fluids from IV lines, and the like. In addition, thevault may allow for easier sterilization and cleaning for subsequentpatient use.

In some embodiments, where appropriate, the flow sensor system 200 issecured to a surface in preparation for giving injections. For example,in some embodiments, referring to FIG. 12, a mount 1100 is used tosecure the flow sensor system 200 to a surface. During this step, it isimportant to avoid kinks in the line between the flow sensor system 200and IV line.

The flow sensor system 200 is now ready for delivery of IV medications.Preferably, any medications given through the flow sensor system 200will be recorded in the electronic base 220 memory. In one embodiment,in the event of a flow sensor system 200 failure (excluding the IV fluidpathway), the flow sensor system 200 will still allow standardmedication or fluid delivery through the port.

Next, giving an injection using the flow sensor system 200 will bediscussed. First, the injection port 130 is cleaned by swabbing the hubaccording to normal hospital procedure. Next, a syringe 800 can beattached to the injection port 130 of the flow sensor 210 by completelyturning the syringe 800 until the syringe 800 stops, i.e., a secureconnection between the syringe 800 and the injection port 130 is made.Ideally, the caregiver double checks each medication name andconcentration on the syringe 800 prior to attachment to the injectionport 130 to assure the correct medication is given. During the injectioncycle and/or medicament determination cycle, when syringe tip 810contacts a syringe protrusion 652, as shown in FIG. 4B, the cantilever650 is deflected radially from the longitudinal axis of the syringe 800.A pad protrusion 651 depresses button 350 on the base 220 and the button350 signals the microprocessor to act.

Next, the drug and concentration displayed and announced by the Computeris verified as the intended drug and concentration. In one embodiment,the base 220 will alert the caregiver that an allergy is detected by analert, for example, by flashing red, green, and yellow lights if amedication allergy is detected. Optionally, the Computer calculates apotential allergy reaction and provides an alert when any of theseconditions is true: (1) an encoded syringe is inserted into the flowsensor 210 and the drug matches the patient's allergy profile; or (2) anon-encoded syringe is inserted into a flow sensor 210 and you select adrug from the select medication screen that matches the patient'sallergy profile. If one of these conditions is true, the allergy alertflag on the Computer configuration is turned on.

In one embodiment, there is no check valve in the flow sensor 210, noris one needed to use the flow sensor 210 safely and effectively.Typically, the flow sensor system 200 measures 0.4 mL to 55 mL perinjection. If the injection flow rate is slow or a small volume isdelivered (<0.4 mL) preferably an alert will display on the Computer.Optionally, an alarm is configured to detect rapid delivery from a largevolume, e.g., 50 mL syringe. In this case, an alert is provided to checkthe dose.

In one embodiment an indicator 375, such as a series of four LEDindicators, turn on in sequence to indicate to the user that fluid ismoving through the flow sensor 210. When base 220 is mounted in thecharger 900, the indicator 375 can indicate a level of battery charge ofthe base 220.

In one embodiment, it is preferred to follow all medication injectionsthrough the flow sensor system 200 with an encoded normal saline flushsyringe to ensure the full dose of medications reaches the patient,especially when successively delivering two incompatible medications.Optionally, the flow sensor system 200 records such saline flushactivity.

In one embodiment, injections are recorded whether or not the flowsensor system 200 is wirelessly connected to the Computer. The base 220stores injection information in its memory and transmits thisinformation upon wireless connection to the Computer.

In one embodiment, the Computer can accommodate multiple flow sensorsystems 200 connected to one patient at a time. An additional flowsensor system 200 may be added at any time during a patient's treatment.When a flow sensor system 200 is connected to a Computer and there is nosyringe attached to the flow sensor 210, the active injection bar reads“Sensor Connected, No syringe”. On the Computer display, a batterystatus icon in the upper right corner of the injection bar indicates thebattery charge level of the base 220 to which the flow sensor 210 isconnected. For each injection a caregiver may enter a comment on theComputer.

The present disclosure provides a flow sensor sub-assembly for sensingflow of a fluidic medicament. The flow sensor sub-assembly includes afirst spring contact and a second spring contact. In one embodiment, thespring contacts are secured to a base that has a circuit for conductingan electrical signal to and from the spring contacts to amicroprocessor. The first spring contact is in electrical communicationwith a first piezo element and the second spring contact is inelectrical communication with a second piezo element. The first springcontact has a first contact force against the first piezo element andthe second spring contact has a second contact force against the secondpiezo element, and the first contact force is equivalent to the secondcontact force. The present disclosure also provides a circuit board forinterfacing to a flow sensor having a plurality of piezo elements fortransmitting a flow signal indicative of flow of a fluidic medicament.

A spring contact of the present disclosure provides electrical contactto a piezo element. For example, a spring contact of the presentdisclosure provides electrical contact to a silvered surface of apiezoelectric crystal. Furthermore this contact provides a spring forceselected to accommodate assembly tolerances, temperature variation,electrical requirements, material selection for a long life to silver,and assembly features for a single-sided printed circuit board assembly(PCBA) attachment. The flow sensor sub-assembly of the presentdisclosure provides for four contacts used in a sensor to have the sameforce on both surfaces of each of two piezo elements, such as crystals,in a single transducer.

A circuit board of the present disclosure provides a single-sided PCBA.The single-sided PCBA of the present disclosure provides a lower costdesign than conventional double-sided PCBA designs. The circuit board ofthe present disclosure also provides a means to maintain mechanicalloading of the crystal contacts when the transducer is inserted to thePCBA.

Electrical contacts to the ultrasound crystal have previously beenaccomplished by soldering wires to a silver coating. A spring contact ofthe present disclosure provides a cost reduction method by using thespring contacts to connect to the crystal. In particular, a single-sidedprinted circuit board (PCB) of the present disclosure provides for alower cost design and a through hole contact design. The design of thepresent disclosure includes the force exertion by the spring constant,dimension of separation between contacts, material type of the springs,the range of forces necessary, and tolerance control of forces exertedby the spring contact, which are all important to eliminate soldering.If soldering is too hot, it often takes silver off the surface of thecrystal. Another problem with soldering is leaving too much solderbehind, which may also cause loading of the ultrasonic physicalcharacteristics. Consistent electrical and physical contact(repeatability) for both crystals is important as well as sensor tosensor calibration. The forces cannot be too high (potential for aslurry to develop) or too low (variable impedance).

The flow sensor sub-assembly of the present disclosure provides a highvolume, disposable design with benefits for its cost, reliability, andrepeatability. The flow sensor sub-assembly of the present disclosureallows for future automation features. The flow sensor sub-assembly ofthe present disclosure provides for maximal tolerance designed inconditions. The flow sensor sub-assembly of the present disclosure isable to fit inside the housing of a flow sensor 210.

Referring to FIGS. 8, 13, and 15, a sub-assembly 10 for a flow sensor210 for sensing flow of a fluidic medicament generally includes a flowtube 100 having a flow tube inlet 102 and a flow tube outlet 101,through which a medicament flows, a first piezo element 150 arranged atan upstream position of the flow tube 100 and a second piezo element 151arranged at a downstream position of the flow tube 100, a first springcontact 750, and a second spring contact 750. In one configuration, thesub-assembly 10 for a flow sensor 210 may be utilized as a flow sensor210 and inserted into the base 220, where contacts 750 are integratedinto the base 220 rather than as a component of a housing 211, 212 ofthe flow sensor 210. Preferably, the upstream transducer 150 anddownstream transducer 151 are interchangeable, however, it is envisagedthat they may be purposefully constructed for their respective positionson the flow sensor sub-assembly 10.

In one embodiment, the first piezo element 150 and the second piezoelement 151 are mounted apart a pre-selected distance from each other.In one embodiment, each of the spring contacts 750 are secured to abase, e.g., a circuit board 700. The circuit board 700 includes acircuit for conducting an electrical signal to and from the springcontacts 750 to a microprocessor. The first spring contact 750 is inelectrical communication with the first piezo element 150 and the secondspring contact 750 is in electrical communication with the second piezoelement 151. The first spring contact 750 has a first contact forceagainst the first piezo element 150 and the second spring contact 750has a second contact force against the second piezo element 151. In oneembodiment, the first contact force is equivalent to the second contactforce. In another embodiment, circuit board 700 can contain anon-volatile memory containing the serial number of the sensor 210,calibration data and/or flow calculation constants for communication tothe electronic microprocessor of the base 220.

In one embodiment, the flow tube 100 includes an inner flow tube 100 andend fittings, e.g., an inlet fitting 180 at an inlet end 102 and anoutlet fitting 190 at an outlet end 101, for securing the inner flowtube to the respective end fittings 180, 190. In one embodiment, thefirst and second piezo elements 150, 151 are mounted to the end fittings180, 190.

In one embodiment, the circuit is formed integrally with a flow sensorhousing by injection molding. In one embodiment, referring to FIG. 8,the assembly may include a flow sensor upper housing 211 engageable witha flow sensor lower housing 212 about the flow sensor 210. In oneembodiment, the first piezo element 150 and the second piezo element 151are annular in shape and encircle the flow tube 100 at each respectivemounting point.

Referring to FIGS. 1-9, 13, and 15, in one embodiment, the flow sensor210 sub-assembly of the present disclosure is contained within a flowsensor housing 211, 212. A portion of the flow sensor housing 212 iscoupled to a flow sensor base 220 which contains a microprocessor and acircuit that includes connecting pins for providing an electrical signalfrom the flow sensor 210 sub-assembly to the microprocessor within theflow sensor base 220.

In some embodiments, the flow sensor 210 sub-assembly is disposed afterthe flow sensor 210 sub-assembly is used to sense the flow of at leastone fluidic medicament. In some embodiments, the flow sensor base 220 isreusable and is usable with different flow sensor 210 sub-assemblies.

Referring to FIGS. 8, 13, and 15, a circuit board 700 of the presentdisclosure for interfacing to a flow sensor 210 that includes piezoelements 150, 151 for transmitting a flow signal indicative of a flow ofa fluidic medicament includes a base or circuit board 700, a first pairof spring contacts 750, a second pair of spring contacts 750, and aplurality of pins 385 in electrical contact with a plurality ofelectrical circuit traces. In one embodiment, the circuit board 700includes a plurality of electrical circuit traces having a first end anda second end.

Referring to FIGS. 8 and 15, the first pair of spring contacts 750 forbias and electrical interface with a first piezo element 150 are mountedto a first end of the circuit board 700 and are in electricalcommunication with at least one electrical circuit trace. Also, thesecond pair of spring contacts 750 for bias and electrical interfacewith a second piezo element 151 are mounted to a second end of thecircuit board 700 and are in electrical communication with at least oneelectrical circuit trace. The plurality of pins 385 are in electricalcontact with the plurality of electrical circuit traces and configuredto form electrical contacts with the plurality of contacts 386. In oneembodiment, each of the spring contacts 750 are pre-configured such thatthe bias against the first piezo element 150 and the bias against thesecond piezo element 151 are equivalent and the electrical circuittraces are configured such that each of the pins and contacts 385, 386are in electrical communication with a single spring contact 750.

In one embodiment, the circuit board 700 is formed integrally with aflow sensor housing 211, 212 by injection molding. The circuit board 700may be assembled into a flow sensor housing 211, 212 in at least twoorientations and provides transmission of a flow signal from the piezoelements 150, 151 to a microprocessor. In one embodiment, the circuitboard 700 is disposed of after a flow sensor 210 is used to sense theflow of at least one fluidic medicament. Advantageously, after a flowsensor 210 is used to sense the flow of at least one fluidic medicament,the circuit board 700 is usable with a different flow sensor 210.

Referring to FIGS. 1, 5A, 5B, 7, and 15-18, a cross-component electricalcircuit is formed by the plurality of pins 385 engaging the plurality ofcontacts 386 when the flow sensor 210 is mounted onto the base 220. Asdescribed herein, the pins 385 are in electrical communication with thepiezo elements 150, 151 and/or an internal controller and memory of theflow sensor 210. The contacts 386 are in electrical communication with acontroller circuitry 1802 in the base 220. The cross-componentelectrical circuit enables electrical communication between the flowsensor 210 and the base 220. For example, the flow sensor 210 can sendsignals from the piezo elements 150, 151 representing characteristics orattributes of the flow of the medicament in the flow tube 100 via thecross-component electrical circuit formed by the connection between thepins 385 and the contacts 386 to the controller circuitry 1802 in thebase 220.

The controller circuitry 1802 comprises a flow measurement circuit 1804including hardware, such as a microprocessor and/or software configuredto execute a flow algorithm to analyze the flow of the fluidicmedicament based on the characteristics or attributes of the fluid flow,e.g., fluid type, flow rate, dose time, etc., received from the flowsensor 210, a microprocessor 1806, such as a SAM 4 microprocessorincluding memory and a clock, configured to control the flow measurementcircuit 1804, and a wireless transmitter 1808 configured to becontrolled by the microprocessor 1806 to communicate with one or moreexternal computing devices. Although FIGS. 16 and 17A-C are describedmainly with respect to wireless communications between elements therein,in some embodiments the wireless communications and connections can bewired communications and connections.

The controller circuitry 1802 is configured to generate an operationmodification signal in response to one or more characteristics orattributes of the fluid flow matching one or more conditions specifiedby one or more rules. For example, the controller circuitry 1802 canexecute the flow algorithm based on data representing characteristics orattributes of the fluid flow received from the piezo elements 150, 151and/or the digital camera disposed within or behind a first window 360(FIGS. 2, 5A, and 5B). The controller circuitry 1802 controls thewireless transmitter 1808 to transmit the operation modification signalcalculated based on the characteristics or attributes of the fluid flowand the one or more conditions specified by the one or more rules to anexternal computing device, e.g., a Display and Data Processing Module1810 including display and data processing software. For example, insome embodiments, if a fluid type is determined to be a different typethan a desired fluid type, or if a flow rate is determined to be adifferent flow rate than a desired flow rate, the controller circuitry1802 can control the wireless transmitter 1808 to transmit an operationmodification signal to the Display and Data Processing Module 1810 thatcauses the module 1810 to display an alarm or alert or causes the module1810 to transmit a signal back to the system 200 that stops the fluidflow. The controller circuitry 1802 can further control the wirelesstransmitter 1808 to transmit injection data representing a type ofmedication, a dose of a medication, and/or a time of a dose of amedication to the Display and Data Processing Module 1810. In someembodiments, the controller circuitry 1802 can automatically transmitthe data to the module 1810 in response to an automated injection.

The Display and Data Processing Module 1810 can includes a wirelesstransmitter, such as a dongle-type transmitter, configured tocommunicate with the wireless transmitter 1808 of the base 220, and acomputing device including a microcontroller and memory, such as atablet micro-computer. The Display and Data Processing Module 1810 isconfigured to execute display and data processing software thatcomprises a message decoder and display driver, an information display,recording system and history log/memory, and a software user interface.The Display and Data Processing Module 1810 is configured to receiveflow modification signals and data representing the operation of theflow sensor from the flow sensor system 200 (and clinical data from aserver computer 1812 discussed below) and analyze and present the datato a user via the user interface, as well as control operations of thesystem 200, such as starting up or shutting down fluid flows. Forexample, the Display and Data Processing Module 1810 can display a typeof fluid, a flow rate, a dose history, a dose time, patient information,and other characteristics or attributes associated with or related tothe fluid flow based on the characteristics and attributes of the fluidflow received from the controller circuitry 1802, as well as issuealarms or alerts to a user based thereon. The Display and DataProcessing Module 1810 can further transmit data representing a dosehistory, manually entered events, system start/stop, and/or shutdown,and/or pre-operative information to the controller circuitry 1802.

The Display and Data Processing Module 1810 is configured to communicatewith a server computer 1812. The Display and Data Processing Module 1810is configured to exchange clinical data with the server computer 1812.The server computer 1812 can include or be connected to a databasestoring clinical data, e.g., medical event data, patient info, alerts,etc., and/or a database storing confirmation files and formulary files,e.g., data representing device use and drug use. The server computer1812 can be connected to or part of a hospital network services system.

In some embodiments, as described herein, the base 220 includes anactivation/engagement button 350 which allows for an indication that theflow sensor 210 has been engaged with the base 220. In one embodiment,the activation/engagement button 350 signals to the control circuitry1802 within the base 220 that the flow sensor 210 has been properlyengaged with the base 220. In another embodiment, theactivation/engagement button 350 signals to the control circuitry 1802within the base 220 that the syringe 800 has been properly engaged withthe flow sensor 210. The control circuitry 1802 can be configured toinitiate operations or activate the flow sensor 210 in response toreceiving the activation signal.

In some embodiments, as described herein, the base 220 of the flowsensor system 200 includes optics and a digital camera disposed withinor behind a first window 360 (FIG. 2) capable of reading the machinereadable indicia 854 provided on a syringe label 850 of an encodedsyringe. An axis of the optics and digital camera extends through thefirst window 360. When the flow sensor 210 is properly mounted on thebase 220, the machine readable indicia 854 provided on a label 850 isaligned with the axis of the optics and digital camera. For example, asshown in FIG. 18A-D, when properly mounted, the camera of the base 220can read the machine readable indicia 854 provided on the syringe label850. The microprocessor of the base 220 is configured to generate anoperation modification signal in response to one or more attributes ofthe machine readable indicia 854 matching one or more conditionsspecified by one or more rules. For example, if a type and/or dose ofthe medicament to be dispensed and indicated by the indicia 854satisfies the one or more conditions specified by one or more rules,e.g., a proper dose at a proper time for a particular patient. Thewireless transmitter of the base 220 is configured to transmit theoperation modification signal to an external device, such as the displayand data processing module 1810. The Display and Data Processing Module1810 is configured to modify one or more operating parameters based onthe operation modification signal. For example, the Display and DataProcessing Module 1810 can issue an alarm or alert if the type, dose, ortime of the medicament does not satisfy the one or more conditionsspecified by the one or more rules. The Display and Data ProcessingModule 1810 can issue a safety alarm or alert command and turn onindicators in the base 220 to alert a clinician visually, at the pointof syringe attachment to the flow sensor, providing immediate indicationof a cautionary condition and allowing the clinician an opportunity tomodify his/her treatment, such as a drug injection, to avoid anincorrect dosage or delivery.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A system for sensing medicament delivery andtransmitting an operation modification signal having at least twoseparable components comprising: a first component comprising a flowsensor having: a fluid port having a flow tube; a fluid inlet at a firstend of the flow tube adapted to couple to an outlet of a fluid source; afluid outlet at a second end of the flow tube adapted to deliver fluidfrom the fluid source to a fluid pathway that provides fluid to apatient; at least one sensor to characterize at least one attribute ofthe fluid from the fluid source; and at least one pin in electricalcommunication with the at least one sensor; and a second componentcomprising a base having: at least one contact; a controller inelectrical communication with the at least one contact that generates atleast one operation modification signal in response to at least oneattribute matching at least one condition specified by at least onerule; a transmitter for wirelessly transmitting the operationmodification signal to at least one device, the operation modificationsignal, when received by the at least one device, causing the at leastone device to modify at least one operating parameter; and across-component electrical circuit, wherein the flow sensor is mountableonto the base and said cross-component electrical circuit is aconnection made by said contacts engaging said pins.
 2. The systemaccording to claim 1, wherein the flow sensor further comprises endfittings adapted for securing the flow tube to the end fittings and afirst piezo element and a second piezo element that are mounted to theend fittings.
 3. The system according to claim 1, wherein said flow tubeis a stainless steel material.
 4. The system according to claim 2,wherein said first piezo element and said second piezo element areannular in shape and encircle the flow tube at each respective mountingpoint.
 5. The system according to claim 1, wherein said flow sensor isdisposed of after use to generate one operation modification signal. 6.The system according to claim 5, wherein the base is used with adifferent flow sensor.
 7. The system according to claim 1, wherein theflow sensor further comprises cantilevered wings adapted for securingthe flow sensor to the base.
 8. The system according to claim 1, whereinthe flow sensor further comprises a follower and said base furthercomprises a cam wherein said follower follows at least a portion of saidcam when said flow sensor is mounted to the base.
 9. The systemaccording to claim 1, wherein the flow sensor further comprises anopening and said base further comprises a protrusion wherein saidopening is sized and shaped to engage said protrusion and saidprotrusion enters said opening when said flow sensor is mounted to saidbase.
 10. The system according to claim 8, wherein the flow sensorfurther comprises an opening and said base further comprises aprotrusion wherein said opening is sized and shaped to engage saidprotrusion and said cam is adapted to move said at least one pin awayfrom said protrusion while said protrusion enters said opening when saidflow sensor is mounted to said base.
 11. The system according to claim10, wherein the flow sensor further comprises at least one cantileveredwing having a tab adapted for securing the flow sensor to the base byengagement of said tab to at least one lip in the base.
 12. The systemaccording to claim 9, wherein the flow sensor further comprises at leastone cantilevered wing having a tab adapted for securing the flow sensorto the base by engagement of said tab to at least one lip in the base.13. The system according to claim 12, wherein the at least onecantilevered wing is deflectable in a direction to allow said tab torelease from said at least one lip, thereby allowing said flow sensor tobecome de-mounted from said base.
 14. The system according to claim 11,wherein the at least one cantilevered wing is deflectable in a directionto allow said tab to release from said at least one lip thereby allowingsaid flow sensor to become de-mounted from said base.
 15. The systemaccording to claim 12, wherein the at least one cantilevered wing is apair of cantilevered wings.
 16. The system according to claim 11,wherein the at least one cantilevered wing is a pair of cantileveredwings.
 17. The system according to claim 12, wherein the at least onecantilevered wing is a pair of cantilevered wings and each respectivewing is arranged opposite each other and said opening is spaced awayfrom said wings and said opening has a center position which bisects adistance between said cantilevered wings and the follower is a pair offollowers and each respective follower is arranged opposite each otheron said flow sensor.
 18. The system according to claim 11, wherein theat least one cantilevered wing is a pair of cantilevered wings and eachrespective wing is arranged opposite each other and said opening isspaced away from said wings and said opening has a center position whichbisects a distance between said cantilevered wings.
 19. The systemaccording to claim 1, further comprising a seal for a liquid-tightengagement between said flow sensor and said base, wherein said sealsurrounds said cross-component electrical circuit, thereby sealing saidcross-component electrical circuit from contamination by a liquid. 20.The system according to claim 1, wherein the flow sensor furthercomprises cantilevered wings having a tab adapted for securing the flowsensor to the base by engagement of said tab to a lip in the base.
 21. Asystem for sensing medicament delivery and transmitting an operationmodification signal having at least two separable components comprising:a first component comprising a flow sensor having: a fluid port having aflow tube; a fluid inlet at a first end of the flow tube adapted tocouple to an outlet of a fluid source; a fluid outlet at a second end ofthe flow tube adapted to deliver fluid from the fluid source to a fluidpathway that provides fluid to a patient; at least one sensor tocharacterize at least one attribute of the fluid from the fluid source;and a movable detector which detects a coupling of the outlet of saidfluid source to said fluid inlet of said flow sensor; and a secondcomponent comprising a base having: a controller that generates theoperation modification signal in response to at least one attributematching at least one condition specified by at least one rule; a switchfor activating said controller; and a transmitter for wirelesslytransmitting the operation modification signal to at least one device,the operation modification signal, when received by the at least onedevice, causing the at least one device to modify at least one operatingparameter, wherein the flow sensor is mountable onto the base and saidmovable detector engages said switch, thereby activating saidcontroller.
 22. The system according to claim 21, wherein the flowsensor further comprises cantilevered wings adapted for securing theflow sensor to the base.
 23. The system according to claim 21, whereinthe flow sensor further comprises a follower and said base furthercomprises a cam wherein said follower follows at least a portion of saidcam when said flow sensor is mounted to the base.
 24. The systemaccording to claim 21, wherein the flow sensor further comprises anopening and said base further comprises a protrusion wherein saidopening is sized and shaped to engage said protrusion and saidprotrusion enters said opening when said flow sensor is mounted to saidbase.
 25. The system according to claim 23, wherein the flow sensorfurther comprises an opening and said base further comprises aprotrusion wherein said opening is sized and shaped to engage saidprotrusion and said cam is adapted to move a pin away from saidprotrusion while said protrusion enters said opening when said flowsensor is mounted to said base.
 26. The system according to claim 21,wherein the flow sensor further comprises cantilevered wings having atab adapted for securing the flow sensor to the base by engagement ofsaid tab to a lip in the base.
 27. The system according to claim 21,wherein the movable detector further comprises a cantilevered beamprotruding from a portion of said flow sensor, said cantilevered beamhaving a free end which engages said switch by deflection of saidcantilevered beam.
 28. The system according to claim 21, wherein themovable detector further comprises a cantilevered beam protruding from aportion of said flow sensor, said cantilevered beam having a free endhaving an outlet engaging portion extending in a direction generallyperpendicular to said cantilevered beam.
 29. The system according toclaim 28, wherein the movable detector further comprises a switchengaging portion of said free end extending in a direction generallyopposite to said outlet engaging portion.
 30. A system for sensingmedicament delivery and transmitting an operation modification signalhaving at least two separable components comprising: a first componentcomprising a flow sensor having: a fluid port having a flow tube; afluid inlet at a first end of the flow tube adapted to couple to anoutlet of a fluid source having a target; a fluid outlet at a second endof the flow tube adapted to deliver fluid from the fluid source to afluid pathway that provides fluid to a patient; and at least one sensorto characterize at least one attribute of the fluid from the fluidsource; and a second component comprising a base having: a portal; acontroller in communication with an optical sensor having an axis thatextends through said portal and inputs a signal to said controller andwherein said controller generates at least one operation modificationsignal in response to the at least one attribute matching at least onecondition specified by at least one rule; and a transmitter forwirelessly transmitting the operation modification signal to at leastone device, the operation modification signal, when received by the atleast one device, causing the at least one device to modify at least oneoperating parameter, wherein when the flow sensor is mounted onto thebase said optical sensor axis is aligned with said target.
 31. Thesystem according to claim 30, wherein the target is indicia on saidoutlet of said fluid source.
 32. The system according to claim 30,wherein the flow sensor further comprises a follower and said basefurther comprises a cam wherein said follower follows at least a portionof said cam when said flow sensor is mounted to the base.
 33. The systemaccording to claim 30, wherein the flow sensor further comprises anopening and said base further comprises a wedge-like protrusion whereinsaid opening is sized and shaped to accommodate a widest portion of saidwedge-like protrusion and said optical sensor axis is aligned with saidtarget when said widest portion enters said opening as said flow sensoris mounted to said base.
 34. The system according to claim 32, whereinthe flow sensor further comprises an opening and said base furthercomprises a protrusion wherein said opening is sized and shaped toengage said protrusion and said cam is adapted to move a pin away fromsaid protrusion while said protrusion enters said opening when said flowsensor is mounted to said base, and when said follower is at a finalposition of said cam, said optical sensor axis is aligned with saidtarget.